Takehome: Hubei has officially opened filing management for first-imported non-special use cosmetics.
The former CFDA previously outlined plans to expand Shanghai Pudong filing management to another 10 FTZs (see CL News). The trial area has now extended to Hubei province where the pilot program officially began on June 5.
From Jun 5, 2018 to Dec 21, 2018, non-special use cosmetics are eligible for filing management instead of registration if they are imported through the ports approved by the State in Wuhan, Yichang, Xiangyang administrative areas* for the first time and the domestic responsible person is registered in the Hubei free trade zone. The domestic responsible person can import products in accordance with relevant regulations only when a filing certificate generated by the filing system is obtained. The authorization of a domestic responsible person shall clearly specify associated product scope, ensuring that the same product is not authorized to different domestic legal responsible persons.
For the convenience of importers, provincial FDA has established a filing information receiving portal in Hubei FTZ Wuhan area dealing with the matters such as the releasing of online username and initial password, the review of online filings and the receiving of paper documents. Additionally, supervisory department of FDA at all levels shall take charge of domestic responsible person, who is responsible for the import and operation of imported non-special use cosmetics and shoulders responsibility for quality and safety according to law, within their respective jurisdictions. Supervisory department shall also strengthen in-process and post-marketing surveillance and enhance coordination with entry-exit inspection and quarantine departments and other relevant departments.
Note (*): considering there is no import port in Hubei free trade zone, SAMR approved the import of cosmetics through ports approved by the State in Wuhan, Yichang, Xiangyang administrative area.
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